NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

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Brief Title

NBI-98854 Dose Titration Study for the Treatment of Tardive Dyskinesia

Official Title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Dose-Titration Study to Assess the Safety, Tolerability, and Efficacy of NBI-98854 for the Treatment of Tardive Dyskinesia

Brief Summary

      The purpose of this study is to evaluate the efficacy, safety, and tolerability of NBI-98854
      (titrated to a subject's optimal dose in the range of 25 to 75 mg) administered once daily
      for the treatment of Tardive Dyskinesia (TD) symptoms.
    

Detailed Description

      This is a Phase 2, randomized, double-blind, placebo-controlled, dose-titration study to
      evaluate the efficacy, safety, and tolerability of NBI-98854 (titrated to subject's optimal
      dose in the range of 25 to 75 mg) compared to placebo, administered once daily (q.d.) for a
      total of 6 weeks of treatment. Approximately 90 medically stable male and female subjects
      with one of the following clinical diagnoses will be enrolled: schizophrenia or
      schizoaffective disorder with neuroleptic-induced TD; mood disorder with neuroleptic-induced
      TD; or gastrointestinal disorder with metoclopramide-induced TD.

      For subjects randomized to active treatment, the starting dose will be 25 mg NBI 98854, which
      may be escalated in increments of 25 mg every 2 weeks to a maximum of 75 mg to achieve an
      optimal dose of NBI-98854 for each subject
    

Study Phase

Phase 2

Study Type

Interventional


Primary Outcome

Abnormal Involuntary Movement Scale (AIMS) Dyskinesia Total Score Change From Baseline at Week 6

Secondary Outcome

 Clinical Global Impression - Global Improvement of TD (CGI-TD) at Week 6

Condition

Tardive Dyskinesia

Intervention

NBI-98854

Study Arms / Comparison Groups

 NBI-98854
Description:  Dose titration to determine a subject's optimal dose in the range of 25 to 75 mg NBI-98854. Dose titration is performed in increments of 25 mg. NBI-98854 administered as one (1) 25 mg capsule, two (2) 25 mg capsules, or one (1) 25 mg capsule and one (1) 50 mg capsule by mouth, taken every morning between 7:00am - 10:00am for 6 weeks.

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Drug

Estimated Enrollment

102

Start Date

December 2012

Completion Date

December 2013

Primary Completion Date

December 2013

Eligibility Criteria

        Inclusion Criteria:

          -  Have one of the following clinical diagnoses for at least 3 months prior to screening
             a) schizophrenia or schizoaffective disorder; b) mood disorder; or c) gastrointestinal
             disorder (e.g., gastroparesis, gastroesophageal reflux disease)

          -  Have a clinical diagnosis of neuroleptic-induced tardive dyskinesia for at least 3
             months prior to screening.

          -  Be receiving a stable dose of antipsychotic medication for a minimum of 30 days before
             study start. Subjects who are not using antipsychotic medication must have stable
             psychiatric status.

          -  Have the doses of concurrent medications and the conditions being treated be stable
             for a minimum of 30 days before study start and be expected to remain stable during
             the study.

          -  Subjects of childbearing potential must agree to use hormonal or two forms of
             nonhormonal birth control during the study.

          -  Female subjects must not be pregnant.

          -  Be in good general health and expected to complete the clinical study as designed.

          -  Have a body mass index (BMI) of 18 to 38 kg/m2 (both inclusive).

          -  Have a negative urine drug screen (negative for amphetamines, barbiturates,
             benzodiazepine, phencyclidine, cocaine, opiates, or cannabinoids) at screening and
             study start, except for any subject receiving a stable dose of benzodiazepine.

          -  Have a negative alcohol breath test at screening and study start.

        Exclusion Criteria:

          -  Have an active clinically significant unstable medical condition within 1 month (30
             days) prior to screening.

          -  Have a history of substance dependence or substance (drug) or alcohol abuse within the
             3 months before study start(nicotine and caffeine dependence are not exclusionary).

          -  Have a known history of neuroleptic malignant syndrome.

          -  Have a significant risk of suicidal or violent behavior.

          -  Receiving any excluded concomitant medication such as reserpine, metoclopramide,
             stimulants, or tetrabenazine.

          -  Receiving medication for the treatment of tardive dyskinesia.

          -  Have a positive human immunodeficiency virus antibody, (HIV-Ab), hepatitis B surface
             antigen (HBsAg), or hepatitis C virus (HCV) antibody result at screening or have a
             history of positive result.

          -  Have received an investigational drug within 30 days before screening or plan to use
             an investigational drug (other than NBI-98854) during the study.

          -  Have an allergy, hypersensitivity, or intolerance to tetrabenazine.

          -  Have had previous exposure with NBI-98854.
      

Gender

All

Ages

18 Years - 85 Years

Accepts Healthy Volunteers

No

Contacts

Chris O'Brien, MD, , 

Location Countries

Puerto Rico

Location Countries

Puerto Rico

Administrative Informations


NCT ID

NCT01733121

Organization ID

NBI-98854-1202


Responsible Party

Sponsor

Study Sponsor

Neurocrine Biosciences


Study Sponsor

Chris O'Brien, MD, Study Director, Neurocrine Biosciences


Verification Date

July 2017